phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 51 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), ... | null | Ovarian Cancer Peritoneal Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 900 mg/m2, intravenous (IV), every 21 days, until disease progression | intervention 1: pemetrexed | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00461786 | |
[
5
] | 1,392 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg. | The study is designed to be conducted in a realistic General Practice (GP) setting, enrolling typical Gastro-oesophageal Reflux Disease (GORD) patients that present for treatment, and for whom a Proton Pump Inhibitor (PPI) would normally be prescribed. The study will be conducted over a 4-week period on the basis that ... | Gastro-oesophageal Reflux | Gastroesophageal Reflux Heartburn Proton pump inhibitor GORD | null | 3 | arm 1: Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily arm 2: Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily arm 3: Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily intervention 2: 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily intervention 3: 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily | intervention 1: Esomeprazole intervention 2: Rabeprazole intervention 3: Esomeprazole | 25 | Belconnen | N/A | Australia | 149.06627 | -35.23798
Bondi Junction | N/A | Australia | 151.24723 | -33.89275
Brookvale | N/A | Australia | 151.27446 | -33.76108
Browns Plains | N/A | Australia | 146.63866 | -36.0472
Campbelltown | N/A | Australia | 150.81667 | -34.06667
Campsie | N/A | Australia | 151.10279 | -33.9125
... | 0 | NCT00464308 |
[
4
] | 216 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin). | IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. Incobotulinum... | Upper Limb Spasticity | null | 2 | arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the... | [
0,
1
] | 1 | [
0
] | intervention 1: active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Di... | intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") | 27 | Hermagor | N/A | Austria | 13.36722 | 46.62722
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Vienna | N/A | Austria | 16.37208 | 48.20849
Besançon | N/A | France | 6.01815 | 47.24878
Garches | N/A | France | 2.18232 | 48.84226
Lille | N/A | France | 3.05858 | 50.63297
Paris | N/A | France | 2.3488 | 48.85341
Beelitz-... | 0 | NCT00465738 | |
[
4
] | 122 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 0ALL | false | Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respirati... | Emergence agitation (EA) from general anesthesia is a frequent phenomenon in children age 1-10 yrs recovering from anesthesia that demands increasing nursing care in the PACU, delays reunion with parents and often causes dissatisfaction for parents, and may lead to adverse sequelae in some cases such as physical harm t... | Obstructive Sleep Apnea | obstructive sleep apnea tonsillectomy adenoidectomy | null | 2 | arm 1: fentanyl bolus 1ug.kg-1 arm 2: dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1 | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion intervention 2: 1 microgram/kilogram as a bolus | intervention 1: dexmedetomidine intervention 2: fentanyl | 1 | Newark | New Jersey | United States | -74.17237 | 40.73566 | 0 | NCT00468052 |
[
5
] | 135 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia. | Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities tha... | Chronic Insomnia | Chronic Insomnia Sleep Initiation and Maintenance Disorder Drug Therapy | null | 2 | arm 1: Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. arm 2: Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. intervention 2: Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 1... | intervention 1: Ramelteon and zolpidem intervention 2: Placebo and zolpidem | 41 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Anaheim | California | United States | -117.9145 | 33.83529
Fountain Valley | California | United States | -117.95367 | 33.70918
La Mesa | California | United States | -117.02308 | 32.76783
Los Angeles | California | United States | -118.24368 | 34.05223
Redl... | 0 | NCT00492232 |
[
4
] | 217 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To assess the efficacy and safety of efficacy of MTS compared to placebo | To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD. | ADHD | null | 2 | arm 1: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear arm 2: Daily application of matching MTS Placebo Patch | [
0,
2
] | 2 | [
0,
0
] | intervention 1: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear intervention 2: Placebo patch | intervention 1: methylphenidate transdermal system intervention 2: Placebo | 32 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Lafayette | California | United States | -122.11802 | 37.88576
Wildomar | California | United States | -117.28004 | 33.59891
Gainesville | Florida | United States | -82.32483 | 29.65163
South Miami | Florida | United States | -80.29338 | 25.7076
Roswell | Geo... | 0 | NCT00499863 | |
[
5
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Patients who are admitted to subacute rehabilitation facilities following hospitalization are frequently anemic. The purpose of this study is to see if anemic patients treated with epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and 12 weeks after study entry compared to patients... | Anemia is associated with loss of function in some studies. However, it is unknown if more rapid correction of anemia in patients who enter a rehabilitation setting after surgery or from hospitalization for acute medical problems leads to shorter rehabilitation stays and improved functional status.
Patients aged 60 an... | Anemia | anemia function rehabilitation | null | 2 | arm 1: Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks arm 2: 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks | [
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: placebo intervention 2: epoetin alpha intervention 3: Niferex | 2 | Cranbury | New Jersey | United States | -74.51376 | 40.31622
East Brunswick | New Jersey | United States | -74.41598 | 40.42788 | 0 | NCT00511901 |
[
3
] | 361 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bl... | A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus... | Diabetes Mellitus, Type 2 | GLP-1, Type 2 Diabetes, pharmacokinetics, pharmacodynamics, GSK716155, metformin, exenatide Type 2 Diabetes Mellitus | null | 0 | null | null | 1 | [
0
] | intervention 1: Albiglutide weekly subcutaneous injection or exenatide twice daily injection | intervention 1: Albiglutide (GSK716155) or exenatide | 163 | Anniston | Alabama | United States | -85.83163 | 33.65983
Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Bull Shoals | Arizona | United States | N/A | N/A
Glendale | Arizona | United States | -112.18599 | 33.53865
Jonesboro | Arizona | United States |... | 0 | NCT00518115 |
[
3
] | 280 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo. | null | Hypertension | hypertension high blood pressure | null | 3 | arm 1: Matching Placebo arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 200mg capsule, once daily for 28 days intervention 2: placebo capsule, once daily for 28 days intervention 3: 500mg capsule, once daily for 28 days | intervention 1: PS433540 intervention 2: placebo intervention 3: PS433540 | 15 | Tempe | Arizona | United States | -111.90931 | 33.41477
Lincoln | California | United States | -121.29301 | 38.89156
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Tustin | Ca... | 0 | NCT00522925 |
[
3
] | 85 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety | null | HIV Infections | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: tipranavir intervention 2: ritonavir | 12 | Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552
München | N/A | Germany | 13.31243 | 51.60698
Antella (fi) | N/A | Italy | 11.32233 | 43.72774
Bari | N/A | Italy | 16.86982 | 41.12066
Ferrara | N/A | Italy | 11.62057 | 44.8... | 0 | NCT00530920 | |
[
3
] | 222 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension | null | Glaucoma Ocular Hypertension | null | 2 | arm 1: bimatoprost eye drops arm 2: placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1 drop in each eye daily for 1 month intervention 2: 1 drop in each eye daily for 1 month | intervention 1: bimatoprost eye drops intervention 2: placebo | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00538304 | |
[
4
] | 480 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice). | This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment. | Pediculus Capitis Infestation | head lice | null | 3 | arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 10 minute topical application of product, followed by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen. intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing r... | intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1% | 6 | Ormond Beach | Florida | United States | -81.05589 | 29.28581
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Council Bluffs | Iowa | United States | -95.86083 | 41.26194
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Layton |... | 0 | NCT00545168 |
[
4
] | 558 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice). | This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment. | Pediculosis | Human Head lice | null | 3 | arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 10 minute topical application product, following by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regi... | intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1% | 6 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Beverly Hills | California | United States | -118.40036 | 34.07362
Largo | Florida | United States | -82.78842 | 27.90979
Miamiville | Ohio | United States | -84.29938 | 39.21256
South Euclid | Ohio... | 0 | NCT00545753 |
[
2,
3
] | 95 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection | null | Chronic Hepatitis C | null | 4 | arm 1: Daclatasvir - 1 mg
Placebo - 0 mg arm 2: Daclatasvir - 10 mg
Placebo - 0 mg arm 3: Daclatasvir - 100 mg
Placebo - 0 mg arm 4: Daclatasvir - 0.5 - 200 mg (to be determined)
Placebo - 0 mg | [
1,
1,
1,
1
] | 2 | [
0,
0
] | intervention 1: Oral Solution, Oral, Single Dose intervention 2: Oral Solution, Oral, Single Dose | intervention 1: Daclatasvir intervention 2: Placebo | 7 | Anaheim | California | United States | -117.9145 | 33.83529
Orlando | Florida | United States | -81.37924 | 28.53834
Baltimore | Maryland | United States | -76.61219 | 39.29038
Rochester | Minnesota | United States | -92.4699 | 44.02163
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Philadelphia | Pennsyl... | 0 | NCT00546715 | |
[
3
] | 568 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device. | null | COPD | QMF indacaterol TWISTHALER® device | null | 6 | arm 1: Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 2: Indacaterol 125 μg delivered by the TWISTHALER® devic... | [
0,
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). intervention 2: Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. intervention 3: Placebo TWISTHALER® device intervention 4: Placebo AEROLIZER® device intervention 5: 100 μg / 90 μg salbutamol/albuter... | intervention 1: indacaterol intervention 2: formoterol intervention 3: placebo to indacaterol intervention 4: placebo to formoterol intervention 5: short acting β2- agonist | 75 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Rosario | N/A | Argentina | -60.63932 | -32.94682
Santillán | N/A | Argentina | -58.97963 | -29.46546
Liège | N/A | Belgium | 5.56749 | 50.63373
Santiago | N/A | Chile | -70.64827 | -33.45694
Val Pariso | N/A | Chile | N/A | N/A
Bois-Guillaume | N/A | France | 1.12... | 0 | NCT00557466 |
[
4
] | 156 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The objectives of this trial conducted in early Parkinson's disease (PD) patients are:
* To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific vis... | null | Parkinson Disease | null | 2 | arm 1: Pramipexole Extended Release (ER) once daily arm 2: Pramipexole Immediate Release (IR) once daily | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Pramipexole Extended Release intervention 2: Pramipexole Immediate Release | 36 | Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Bron | N/A | France | 4.91303 | 45.73865
Clermont-Ferrand | N/A | France | 3.08682 | 45.77969
Créteil | N/A | France | 2.46569 | 48.79266
Créteil | N/A | France | 2.46... | 0 | NCT00558025 | |
[
4
] | 91 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indica... | The study was terminated early when the results from Study 11961 (NCT00300885), an earlier Phase 3 study evaluating the effects of Sorafenib in combination with paclitaxel and carboplatin in subjects with advanced NSCLC, showed an overall lack of efficacy of Sorafenib in combination with paclitaxel and carboplatin in N... | Carcinoma, Non-Small-Cell Lung | NSCLC | null | 2 | arm 1: Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 mi... | intervention 1: Sorafenib + Paclitaxel + Carboplatin intervention 2: Placebo + Paclitaxel + Carboplatin | 22 | Guangzhou | Guangdong | China | 113.25 | 23.11667
Guangzhou | Guangdong | China | 113.25 | 23.11667
Shatin | Hong Kong | China | 114.18333 | 22.38333
Nanjing | Jiangsu | China | 118.77778 | 32.06167
Hangzhou | Zhejiang | China | 120.16142 | 30.29365
Hangzhou | Zhejiang | China | 120.16142 | 30.29365
Beijing | N/A | Chi... | 0 | NCT00558636 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy. | This study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. The goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart... | Diabetic Neuropathy | Diabetic neuropathy Pregabalin Lyrica | null | 2 | arm 1: Pregabalin medication arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. intervention 2: Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. | intervention 1: Pregabalin intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00573261 |
[
2,
3
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the perc... | Rationale:
To date, the standard treatment for overactive bladder (including detrusor hyperreflexia and detrusor overactivity) consists of oral anticholinergic medications that can have troublesome side effects and variable efficacy. What's more, patients failing pharmacological therapy must either live with their mal... | Overactive Bladder Detrusor Instability Detrusor Hyperreflexia | null | 1 | arm 1: Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.
All... | [
0
] | 2 | [
0,
0
] | intervention 1: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution. intervention 2: Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO. | intervention 1: Botulinum-A toxin intervention 2: Dimethyl sulfoxide (DMSO) | 1 | Jacksonville | Florida | United States | -81.65565 | 30.33218 | 0 | NCT00583219 | |
[
3
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | true | For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solution... | For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solution... | Large Polyps in the Gastrointestinal Tract | submucosal cushion polypectomy endoscopic mucosal resection | null | 3 | arm 1: Polypectomy with normal saline injected for submucosal cushion creation arm 2: Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion arm 3: Polypectomy after injection of autologous blood | [
1,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion intervention 2: Normal saline will be injected under the lesion to create submucosal cushion intervention 3: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create su... | intervention 1: Autologous blood injection intervention 2: Normal saline intervention 3: HPMC | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00583466 |
[
4
] | 39 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy. | null | Carcinoma, Renal Cell | Sorafenib Nexavar Metastatic RCC Renal Cell Carcinoma Unresectable RCC | null | 1 | arm 1: 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) | [
0
] | 1 | [
0
] | intervention 1: 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) | intervention 1: Sorafenib (Nexavar, BAY43-9006) | 8 | Nanjing | Jiangsu | China | 118.77778 | 32.06167
Beijing | N/A | China | 116.39723 | 39.9075
Shanghai | N/A | China | 121.45806 | 31.22222
Shanghai | N/A | China | 121.45806 | 31.22222
Tainan City | Tainan | Taiwan | 120.21333 | 22.99083
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 2... | 0 | NCT00586105 |
[
4
] | 861 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Safety study for bepotastine besilate ophthalmic solution in normal volunteers | null | Allergic Conjunctivitis | null | 2 | arm 1: bepotastine besilate ophthalmic solution 1.5% arm 2: vehicle | [
0,
2
] | 2 | [
0,
0
] | intervention 1: One drop, both eyes, twice a day intervention 2: One drop, both eyes, twice a day | intervention 1: Bepreve intervention 2: Placebo | 0 | null | 0 | NCT00586625 | |
[
3
] | 132 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome. | Delayed sleep phase syndrome is the most common circadian disorder in adolescents and most adults with the condition report onset of symptoms during childhood or adolescence. Delayed Sleep Phase Syndrome involves a chronic mismatch between the usual daily schedule required by the individual's environment and his or her... | Sleep Disorders, Circadian Rhythm | Delayed sleep phase syndrome; drug therapy | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Ramelteon 1 mg, tablets, orally, once daily for up to two weeks. intervention 2: Ramelteon 4 mg, tablets, orally, once daily for up to two weeks. intervention 3: Ramelteon 8 mg, tablets, orally, once daily for up to two weeks. intervention 4: Ramelteon placebo-matching tablets, orally, once daily for up... | intervention 1: Ramelteon intervention 2: Ramelteon intervention 3: Ramelteon intervention 4: Placebo | 42 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fountain Valley | California | United States | -117.95367 | 33.70918
Glendale | ... | 0 | NCT00593736 |
[
5
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia. | null | Parkinson's Disease | Rotigotine NEUPRO® Parkinson's Disease (PD) perioperative use anaesthesia, | null | 1 | arm 1: Rotigotine | [
0
] | 1 | [
0
] | intervention 1: 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch;
Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h;
One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery. | intervention 1: Rotigotine | 12 | Augsburg | N/A | Germany | 10.89851 | 48.37154
Bochum | N/A | Germany | 7.21648 | 51.48165
Bonn | N/A | Germany | 7.09549 | 50.73438
Bremerhaven | N/A | Germany | 8.57553 | 53.55357
Dortmund | N/A | Germany | 7.466 | 51.51494
Dresden | N/A | Germany | 13.73832 | 51.05089
Hanau | N/A | Germany | 8.91418 | 50.13423
Ingol... | 0 | NCT00594464 |
[
4
] | 117 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The objective of this study is to test the idea that the immediate-release (IR) form of tapentadol (CG5503) can be directly converted into an approximately equivalent total daily dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and efficacy. | This study will establish the dose equivalence and the safety and effectiveness of the Immediate Release (IR) and Extended Release (ER) forms of tapentadol (CG5503) to support the conversion from IR to ER, and ER to IR use. Dose equivalence will be examined in patients diagnosed with moderate-to-severe, chronic Low Bac... | Low Back Pain | Low Back Pain Dose Equivalence Tapentadol (CG5503) Tapentadol-IR Tapentadol-ER | null | 2 | arm 1: tapentadol (CG5503) Immediate Release (IR) Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100 150 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentad... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period intervention 2: During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of do... | intervention 1: tapentadol (CG5503) Immediate Release IR intervention 2: tapentadol (CG5503) Extended Release (ER) intervention 3: tapentadol (CG5503) Immediate Release (IR) | 0 | null | 0 | NCT00594516 |
[
3
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD). | null | Constipation | null | 5 | arm 1: Placebo arm 2: MOA-728 arm 3: MOA-728 arm 4: MOA-728 arm 5: MOA-728 | [
2,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Oral Capsules intervention 2: Placebo | intervention 1: MOA-728 intervention 2: Placebo | 0 | null | 0 | NCT00605644 | |
[
3
] | 112 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia. | null | Chronic Primary Insomnia | insomnia elderly sleeplessness | null | 10 | arm 1: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 2: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 3: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 4: 5-period, ... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 10 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 2: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B ... | intervention 1: ACT-078573 oral capsules at 25 and 100 mg and matching placebo intervention 2: ACT-078573 and matching placebo intervention 3: ACT-078573 and matching placebo intervention 4: ACT-078573 and matching placebo intervention 5: ACT-078573 and matching placebo intervention 6: ACT-078573 and matching placebo i... | 21 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Brandon | Florida | United States | -82.28592 | 27.9378
Miami | Flor... | 0 | NCT00606593 |
[
0
] | 14 | RANDOMIZED | PARALLEL | null | 0NONE | true | 1FEMALE | false | The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring). | The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (... | Contraceptive Usage Vaginal Epithelial Disruption | contraception NuvaRing Desogen vaginal biopsy | null | 2 | arm 1: Drug: ethinyl estradiol and desogestrel
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.
Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles arm 2: Intra... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol intervention 2: Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring | intervention 1: Desogen (ethinyl estradiol and desogestrel) intervention 2: NuvaRing (ethinyl estradiol and etonogestrel) | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00612508 |
[
0
] | 80 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 1SINGLE | true | 1FEMALE | true | The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix). | The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into o... | Pain | surgical abortion pain management | null | 2 | arm 1: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. arm 2: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. intervention 2: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. | intervention 1: Lidocaine intervention 2: Lidocaine | 2 | Portland | Oregon | United States | -122.67621 | 45.52345
Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00613821 |
[
4
] | 167 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence... | Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence... | Hyponatremia | maintenance fluids hyponatremia vasopressin children | null | 3 | arm 1: Normal saline in 5% dextrose at standard maintenance rate arm 2: Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose arm 3: N/5 saline in 5% dextrose at standard maintenance rate | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 0.9% saline with 5% dextrose at standard maintenance rate intervention 2: Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose intervention 3: N/5 saline in 5% dextrose at standard maintenance rate | intervention 1: Isotonic fluid intervention 2: Hypotonic fluid intervention 3: Hypotonic fluid | 1 | New Delhi | National Capital Territory of Delhi | India | 77.2148 | 28.62137 | 0 | NCT00621348 |
[
4
] | 344 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients | This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and... | Patients With Schizophrenia and Acute Agitation | schizophrenia, agitation, inhaled loxapine, ADASUVE | null | 3 | arm 1: Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours arm 2: Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours arm 3: Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo | intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00628589 |
[
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of the abnormal bone architecture, and the anemia and bone marrow failure that is also characteristic of this disease. However, we have found in... | This transplant protocol will test the following: 1) the ability to achieve engraftment with the reduced intensity protocol, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based on differential imaging and biologic evaluations prior to transplantation and at designated points after transpl... | Osteopetrosis | osteopetrosis | null | 1 | arm 1: Patients enrolled and received study treatment. | [
0
] | 3 | [
3,
0,
3
] | intervention 1: Stem Cell (unrelated or matched related donor grafts (both peripheral blood and marrow) infusion on Day 0 and 42; Umbilical Cord Blood on Day 0 and 42 intervention 2: * 12 Campath-1H 0.3 mg/kg intravenously (IV) over 2 hours
* 11 Campath-1H 0.3 mg/kg intravenously over 2 hours
* 10 Campath-1H 0.3 mg/kg ... | intervention 1: Stem Cell or Umbilical Cord Blood Transplantation intervention 2: Campath, Busulfan, Clofarabine intervention 3: Total Lymphoid Irradiation | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00638820 |
[
2
] | 14 | NON_RANDOMIZED | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | true | 0ALL | false | The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects | null | Healthy | Healthy Subjects | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days | intervention 1: Dasatinib + Omeprazole | 1 | Hamilton | New Jersey | United States | -74.08125 | 40.20706 | 0 | NCT00655746 |
[
5
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically. | We give subjects topical benzoyl peroxide, a standard first line acne treatment, in a container that records when the container is opened and closed. Subjects will simply be asked to "return in six weeks to see how well benzoyl peroxide works for them." Subjects initially will not be told that they are participating in... | Acne Vulgaris | null | 1 | arm 1: Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated wi... | [
0
] | 1 | [
0
] | intervention 1: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks. | intervention 1: Benzoyl Peroxide | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00658112 | |
[
3
] | 151 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparis... | null | Pain | Analgesic effect Molar extraction | null | 3 | arm 1: AZD1940 800ug given predose arm 2: Naproxen 500mg given pre-surgery arm 3: Placebo given pre-surgery | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 800ug oral administration intervention 2: 500mg oral administration intervention 3: Placebo given pre-surgery | intervention 1: AZD1940 intervention 2: Naproxen intervention 3: Placebo | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00659490 |
[
3,
4
] | 98 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay). | Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections. | Burn | Burn Wounds Wound infection Topical antimicrobials Cerium Dakins Sulfamylon Soaks Silver Nitrate | null | 1 | arm 1: Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization. | [
0
] | 1 | [
0
] | intervention 1: Application of Sulfamylon and Silver Nitrate Solution to burn wound daily | intervention 1: Sulfamylon 5% and Silver Nitrate Soaks | 1 | Galveston | Texas | United States | -94.7977 | 29.30135 | 0 | NCT00675922 |
[
5
] | 161 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage. | This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound ident... | Skin Diseases, Infectious | skin abscess CA-MRSA | null | 2 | arm 1: Maalox and bitter mixture arm 2: Trimethoprim-sulfamethoxazole suspension | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethopr... | intervention 1: Trimethoprim-sulfamethoxazole intervention 2: Placebo group | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00679302 |
[
4
] | 581 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if two allergy medications are more effective than placebo. | null | Perennial Allergic Rhinitis | null | 3 | arm 1: Placebo arm 2: 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks arm 3: 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 0.15% azelastine hydrochloride 1644 mcg intervention 2: 0.1% azelastine hydrochloride 1096 mcg intervention 3: Placebo | intervention 1: 0.15% azelastine hydrochloride intervention 2: 0.1% azelastine hydrochloride intervention 3: Placebo | 43 | Huntington Beach | California | United States | -117.99923 | 33.6603
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Mission Viejo | California | United States | -117.672 | 33.60002
San Diego | California | United States | -117.16472 | 32.... | 0 | NCT00712920 | |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | false | We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric a... | We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric a... | Osteoporosis | Gastric acid Dietary protein Calcium Intestinal absorption Calcium sensing receptor | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet intervention 2: Placebo 20 mg twice a day for 9 days | intervention 1: esomeprazole intervention 2: Placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00719160 |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG). | null | Angle-closure Glaucoma | IOP lowering efficacy CACG | null | 2 | arm 1: One drop in each eye, once daily at 9 AM arm 2: One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks | [
0,
1
] | 2 | [
0,
0
] | intervention 1: One drop in each eye, once daily at 9 AM intervention 2: One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks | intervention 1: Travoprost 0.004% (Travatan) intervention 2: Pilocarpine 1% | 0 | null | 0 | NCT00762645 |
[
3
] | 35 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase... | Issues on safety are addressed in the Adverse Event section. | Hypertension | null | 3 | arm 1: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning arm 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening arm 3: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning intervention 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening intervention 3: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the ... | intervention 1: Nifedipine (Adalat CR, BAYA1040) 80mg OD intervention 2: Nifedipine (Adalat CR, BAYA1040) 40mg BID intervention 3: Nifedipine (Adalat CR, BAYA1040) 40mg OD | 3 | Sendai | Miyagi | Japan | 140.86667 | 38.26667
Suita | Osaka | Japan | 135.51567 | 34.76143
Koshigaya | Saitama | Japan | 139.78916 | 35.89035 | 0 | NCT00768560 | |
[
5
] | 39 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin. | This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV. | Hepatitis C | Hepatitis C Post Liver Transplant | null | 2 | arm 1: Tacrolimus arm 2: Cyclosporine | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml. intervention 2: Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divide... | intervention 1: Cyclosporine intervention 2: Tacrolimus | 0 | null | 0 | NCT00821587 |
[
2
] | 61 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2. arm 2: Participants ... | [
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods. intervention 2: Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods. intervention 3: Single dose metformin 500 mg tablet afte... | intervention 1: Sitagliptin phosphate/metformin hydrochloride FDC intervention 2: Sitagliptin phosphate intervention 3: Metformin hydrochloride | 0 | null | 0 | NCT00929201 | |
[
3
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a 52-week, multicentric, phase II, pilot study conducted in 40 subjects with early-onset Alzheimer's disease (AD) to evaluate safety, tolerability and clinical efficacy of subcutaneous (sc) interferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] in the treatment of AD by comparing th... | Alzheimer's disease is characterized by progressive cognitive impairment resulting from neuronal loss. The primary pathological feature of the disease is the extracellular deposition of fibrillary amyloid and its compaction into senile plaques. The senile plaque is the focus of a complex cellular reaction involving the... | Alzheimer's Disease | Alzheimer's Dementia Interferon beta-1a Rebif | null | 2 | arm 1: Subjets in this arm received interferon beta-1a (Rebif® 22 mcg tiw) arm 2: Subjects in this arm received placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Interferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] administered subcutaneously (sc) intervention 2: The inactive substance (placebo) looks the same as Interferon beta-1a (Rebif®), and is given the same way | intervention 1: Interferon beta-1a intervention 2: Placebo | 1 | Catania | CT | Italy | 15.07041 | 37.49223 | 0 | NCT01075763 |
[
4
] | 199 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF). | Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to t... | Atrial Fibrillation | PUFA atrial fibrillation | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day intervention 2: 1.0 g of olive oil,one capsule twice a day intervention 3: Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, ... | intervention 1: n-3 PUFAs intervention 2: Placebo intervention 3: RASS inhibitors and/or RAS blockers intervention 4: Amiodarone | 1 | Brescia | Brescia | Italy | 10.21472 | 45.53558 | 0 | NCT01198275 |
[
0
] | 152 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 1FEMALE | true | The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep. | null | Pregnancy Postpartum Period Sleep Disturbance | sleep hygiene actigraphy maternal infant postpartum period immunization acetaminophen | null | 3 | arm 1: Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive no intervention beyond standard immunization care. arm 2: Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.
Infants in this arm receive s... | [
1,
0,
0
] | 3 | [
5,
5,
0
] | intervention 1: This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation.
It is administered to women during their last month of pregnancy. intervention ... | intervention 1: Sleep hygiene intervention 2: Dietary information intervention 3: Acetaminophen | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT01321710 |
[
5
] | 178 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers. | The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.
Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy... | Peptic Ulcer | aspirin peptic ulcer | null | 2 | arm 1: esomeprazole (40 mg/day) for 8 weeks arm 2: esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks | [
4,
1
] | 1 | [
0
] | intervention 1: aspirin, 100 mg, qd x 8 weeks | intervention 1: aspirin | 3 | Kaohsiung | Taiwan | Taiwan | N/A | N/A
Kaohsiung | Taiwan | Taiwan | N/A | N/A
Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 | 0 | NCT01353144 |
[
2
] | 20 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit.
Following surgery, subjects received IN ketorolac 15 mg (weight \< 50 k... | null | Postoperative Pain | null | 2 | arm 1: Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing \<50 kg. arm 2: Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg. intervention 2: Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg. | intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT01363076 | |
[
5
] | 473 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older ... | This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Partici... | Osteoarthritis | Osteoarthritis Celecoxib Tramadol Paracetamol | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy. intervention 2: Celecoxib 200 mg alone once daily for 4 weeks. | intervention 1: Tramadol/Paracetamol (APAP) intervention 2: Non-Tramadol/APAP | 1 | Paranaque City | National Capital Region | Philippines | 121.01749 | 14.48156 | 0 | NCT01728246 |
[
5
] | 1,059 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting. | This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants wi... | Low Back Pain Shoulder Pain Neck Pain | Low back pain Shoulder pain Neck pain Tramadol hydrochloride Paracetamol | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement. | intervention 1: Tramadol HCl-Paracetamol | 0 | null | 0 | NCT01843660 |
[
5
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 3TRIPLE | true | 1FEMALE | false | The purpose of the study is to establish that sustained estrogen levels are the driving force for the LH surge, and are thereby necessary for ovulation to occur. We predict that by reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit ovulation from occurring. | Sine the common understanding of ovulation in a natural cycle suggests that a sustained, elevated estradiol level is required to trigger the LH surge, administration of letrozole throughout the cycle should lower estradiol levels and prevent the LH surge from occurring. In this study, we sought to determine if the LH s... | Ovulation Disorder Ovarian Cysts | null | 2 | arm 1: Control cycle. No intervention. arm 2: 5mg daily | [
4,
0
] | 1 | [
0
] | intervention 1: Letrozole administered daily through the time of ovulation. | intervention 1: Letrozole | 1 | Charlotte | North Carolina | United States | -80.84313 | 35.22709 | 0 | NCT01999569 | |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy. | null | Multiple Myeloma | null | 1 | arm 1: Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months. | [
0
] | 1 | [
0
] | intervention 1: Bevacizumab was provided as a concentrate in vials. | intervention 1: Bevacizumab | 4 | Salzburg | N/A | Austria | 13.04399 | 47.79941
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849 | 0 | NCT02079519 | |
[
3
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack ... | null | Cancer | null | 1 | arm 1: Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Interferon Alfa-2a | 0 | null | 0 | NCT02159482 | |
[
5
] | 180 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunode... | null | Hepatitis C, Chronic | null | 2 | arm 1: Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks. arm 2: Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection. intervention 2: Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) o... | intervention 1: Peg-Interferon Alpha-2A intervention 2: Ribavirin | 17 | Campinas | N/A | Brazil | -47.06083 | -22.90556
Florianópolis | N/A | Brazil | -48.54917 | -27.59667
Itajaí | N/A | Brazil | -48.66194 | -26.90778
Juiz de Fora | N/A | Brazil | -43.35028 | -21.76417
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Recife | N/A | Brazil | -34.88111 | -8.05389
Ribeirão Preto | N/A | B... | 0 | NCT02761629 | |
[
5
] | 2 | RANDOMIZED | SINGLE_GROUP | 4SUPPORTIVE_CARE | 2DOUBLE | false | 1FEMALE | false | RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer. | OBJECTIVES:
* To evaluate the tolerability and usefulness of the dietary supplement, L-carnitine L-tartrate, in the prevention of chemotherapy-induced peripheral neuropathy in women with metastatic breast cancer.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral L-carnitine L-... | Breast Cancer Chemotherapeutic Agent Toxicity Neurotoxicity | neurotoxicity chemotherapeutic agent toxicity stage IV breast cancer recurrent breast cancer | null | 2 | arm 1: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. arm 2: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after co... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Given orally intervention 2: Given orally | intervention 1: L-carnitine L-tartrate intervention 2: placebo | 2 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483 | 0 | NCT00754767 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) and how migalastat works in participants with Fabry disease. | This was a Phase 2, open-label study in male participants with Fabry disease. The study consisted of a 4-week screening period during which participants' genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat via an in vitro assay. Participants were required to have α-Gal A activity re... | Fabry Disease | Amicus Therapeutics AT1001 Galafold Migalastat Substrate | null | 1 | arm 1: Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week extension period. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: migalastat HCl | 2 | Parkville | N/A | Australia | 144.95 | -37.78333
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 | 0 | NCT00283959 |
[
3
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease. | This was a Phase 2, open-label study in female participants with Fabry disease. The study consisted of a 4-week screening period, during which participants' galactosidase (GLA) genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat. Participants were required to have α-Gal A activity r... | Fabry Disease | Amicus Therapeutics AT1001 Galafold Migalastat Substrate | null | 3 | arm 1: Migalastat 50 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period. arm 2: Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period. arm 3: Migala... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: migalastat HCl | 6 | Decatur | Georgia | United States | -84.29631 | 33.77483
Parkville | Victoria | Australia | 144.95 | -37.78333
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Montreal | N/A | Canada | -73.58781 | 45.50884
Paris | N/A | France | 2.3488 | 48.85341
Salford | N/A | United Kingdom | -2.29042 | 53.48771 | 0 | NCT00304512 |
[
3
] | 8 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one f... | This trial will include two separate stages (Ia+Ib and II).
Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recFSH provide an appropriate response in eligible participants meeting all inclusi... | Ovulation Induction | Pharmacological effects of drugs Hormones Hormone Substitutes and Hormone Antagonists Pharmacological Actions Monofollicular growth Randomized Open-label Active-controlled | null | 2 | arm 1: Eligible participants will receive a subcutaneous (SC) injection of corifollitropin alfa (Stage 1a: 15mcg, Stage Ib/II: 30 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient, the participant will receive a second or third dose of ... | [
0,
0
] | 4 | [
0,
2,
2,
2
] | intervention 1: SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg). intervention 2: Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropi... | intervention 1: corifollitropin alfa intervention 2: recombinant Follicle Stimulating Hormone (recFSH) intervention 3: human Chorion Gonadotropin (hCG) intervention 4: hCG Bolus injection | 0 | null | 0 | NCT00697255 |
[
4
] | 94 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. Th... | null | Type 2 Diabetes Mellitus | null | 8 | arm 1: rivoglitazone HCl 0.5mg arm 2: rivoglitazone HCl 1.0 mg arm 3: rivoglitazone HCl 1.5 mg arm 4: placebo matching rivoglitazone HCl tablets arm 5: pioglitazone HCl 15 mg arm 6: pioglitazone HCl 30 mg arm 7: pioglitazone HCl 45 mg arm 8: matching placebo for pioglitazone | [
0,
0,
0,
2,
1,
1,
1,
2
] | 9 | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 0.5 mg tablets administered orally, once daily intervention 2: 1.0 mg tablets administered orally, once daily intervention 3: 1.5 mg tablets administered orally, once daily intervention 4: placebo tablets matching rivoglitazone tablets administered orally, once daily intervention 5: 15 mg capsules admin... | intervention 1: Rivoglitazone HCl intervention 2: rivoglitazone HCl intervention 3: rivoglitazone HCl intervention 4: placebo intervention 5: pioglitazone HCl intervention 6: pioglitazone HCl intervention 7: pioglitazone HCl 45 mg intervention 8: placebo intervention 9: metformin | 18 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Huntsville | Alabama | United States | -86.58594 | 34.7304
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Ridgefield | Connecticut | United States | -73.49818 | 41.28148
Fort Lau... | 0 | NCT00571519 | |
[
5
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Neither the patients or their providers will know i... | Objectives: This study is designed to determine whether spironolactone at a dose of 25 mg per day in patients with implanted cardioverter defibrillators (ICD) will 1) Reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), 2) Improve health related quality of life, 3) Reduce the need for... | Ventricular Arrhythmias | Anti-Arrhythmia Agents Ventricular Fibrillation Ventricular Tachycardia Defibrillators, Implantable | null | 2 | arm 1: Patients randomized to active therapy with spironolactone arm 2: patients randomized to placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: aldosterone blocker intervention 2: identical in appearance to spironolactone study drug | intervention 1: spironolactone intervention 2: placebo | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT04495712 |
[
4
] | 1,791 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-... | Primary Hypothesis: Intensive glycemic control reduces major macrovascular morbidity and mortality compared to standard glycemic control in type 2 diabetics who have failed simple therapy.
Secondary Hypotheses: Intensive glycemic control, compared to standard glycemic control, reduces other macrovascular morbidity and... | Type 2 Diabetes Mellitus | DM glycemic control insulin type 2 diabetes mellitus | null | 2 | arm 1: Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs arm 2: Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to A... | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs Arm 1 Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs, add one injection of insulin Arm 2 intervention 2: Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2 intervention 3: Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2 interventi... | intervention 1: Insulin intervention 2: Glimepiride intervention 3: Rosiglitazone intervention 4: Metformin | 21 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Fresno | California | United States | -119.77237 | 36.74773
Long Beach | California | United States | -118.18923 | 33.76696
San Diego | California | United States | -117.16472 | 32.71571
Miami | Florida | ... | 0 | NCT00032487 |
[
4
] | 259 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression. | Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, ... | Major Depressive Disorder With Psychotic Features | Major depressive disorder with psychotic features Delusional Depression Randomized Trial Combination Treatment SSRI Atypical Antipsychotic | null | 2 | arm 1: sertraline plus olanzapine arm 2: olanzapine (5 - 20mg/day) plus placebo | [
1,
2
] | 3 | [
0,
0,
10
] | intervention 1: 10-20mg/day intervention 2: 150-200mg/day intervention 3: tablet that ressembles sertraline but contains no medication | intervention 1: Olanzapine intervention 2: Sertraline intervention 3: placebo | 4 | Worcester | Massachusetts | United States | -71.80229 | 42.26259
New York | New York | United States | -74.00597 | 40.71427
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 1 | NCT00056472 |
[
5
] | 31,546 | null | PARALLEL | 1PREVENTION | null | false | 0ALL | null | The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarctio... | null | Cardiovascular Diseases | null | 0 | null | null | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Telmisartan intervention 2: Combination of Telmisartan and Ramipril intervention 3: Ramipril | 732 | Athens | Alabama | United States | -86.97219 | 34.80243
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tuscon | Arizona | United State... | 1 | NCT00153101 | |
[
5
] | 139 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients. | null | Renal Transplantation | Renal transplantation everolimus immunosuppressants wound-healing | null | 2 | arm 1: Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. arm 2: Patients received Everolimus 4 weeks after kidney transplant until the end of the study, adm... | [
1,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Everolimus (RAD001) | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 1 | NCT00154297 |
[
4
] | 804 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment. | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD Lung function Exacerbations Quality of Life | null | 2 | arm 1: Aclidinium bromide 200 μg once-daily by inhalation arm 2: Placebo by inhalation | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks intervention 2: Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks | intervention 1: Aclidinium bromide intervention 2: Placebo | 120 | Jasper | Alabama | United States | -87.27751 | 33.83122
Ozark | Alabama | United States | -85.64049 | 31.45906
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United State... | 1 | NCT00358436 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study. | null | Peanut Hypersensitivity | TOPS Peanut allergy Peanut-induced allergy Allergy | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: SC repeating dose | intervention 1: omalizumab | 0 | null | 1 | NCT00382148 |
[
4
] | 307 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder. | Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and ho... | Schizoaffective Disorder Psychotic Disorder | Schizoaffective Disorder antipsychotic paliperidone placebo | null | 3 | arm 1: Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks) arm 2: Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks) arm 3: Placebo for 6 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: for 6 weeks intervention 2: (3-12mg/day in 3 mg/day increments for 6 weeks) intervention 3: (3-12mg/day in 3 mg/day increments for 6 weeks) | intervention 1: Placebo intervention 2: Paliperidone ER intervention 3: Paliperidone ER | 44 | Cerritos | California | United States | -118.06479 | 33.85835
Costa Mesa | California | United States | -117.91867 | 33.64113
Garden Grove | California | United States | -117.94145 | 33.77391
Huntington Beach | California | United States | -117.99923 | 33.6603
Pico Rivera | California | United States | -118.09673 | 33.... | 1 | NCT00412373 |
[
3
] | 1,146 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit. | null | Atrial Fibrillation Thromboembolism | Anti-coagulant Non-valvular Venous Thromboembolism Prevention of Blood Clots Atrial Fibrillation Non-valvular atrial fibrillation | null | 5 | arm 1: DU-176b 30mg tablet once daily arm 2: DU-176b 60mg once daily arm 3: DU-176b 30mg b.i.d. arm 4: DU-176b 60mg tablets two times a day arm 5: warfarin tablets | [
0,
0,
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 30mg tablet once daily intervention 2: 60mg tablet once daily intervention 3: 30mg tablet two times a day intervention 4: 60mg tablet two times a day intervention 5: warfarin tablets | intervention 1: Edoxaban (DU-176b) intervention 2: Edoxaban (DU-176b) intervention 3: Edoxaban (DU-176b) intervention 4: Edoxaban (DU-176b) intervention 5: warfarin | 91 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Anaheim | California | United States | -117.9145 | 33.83529
Beverly Hills | California | United States | -118.40036 | 34.07362
Stockton | California | United States | -121.29078 | 37.9577
Orlando | Florida | United States | -81.37924 | 28.53834
Sarasota | Flori... | 1 | NCT00504556 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-... | This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-... | Graft Rejection Kidney Disease | Immunosuppression Tolerance DSG Alemtuzumab | null | 1 | arm 1: The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression. | [
0
] | 1 | [
0
] | intervention 1: Alemtuzumab was administered intravenously at 0.3 mg/kg/dose over 3 hr. Patients received one dose on each of days -1,+1,+3 and +5 relative to transplantation (total dose 1.2 mg/kg). Methylprednisolone was given prior to each dose to limit the cytokine release: 500 mg prior to dose 1, 125 mg prior to do... | intervention 1: Alemtuzumab and DSG | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00001984 |
[
3
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals will receive treatment for 12 weeks with a followup phase lasting 9 months. | Recently, the first large-scale double-blind, placebo-controlled study of a selective serotonin reuptake inhibitor (SSRI) antidepressant in depressed adolescents was completed (Emslie et al., 1997) That study demonstrated efficacy for fluoxetine in non-AUD adolescents with major depressive disorder (MDD). Our own resea... | Alcoholism Depression | fluoxetine, adolescents, alcohol dependence, major depression Alcoholism | null | 2 | arm 1: fluoxetine plus Treatment As Usual (TAU) arm 2: placebo plus Treatment As Usual (TAU) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up intervention 2: placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up | intervention 1: fluoxetine (Prozac) intervention 2: Placebo plus Treatment As Usual | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00027378 |
[
3,
4
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology... | null | Primary Sclerosing Cholangitis | Urso PSC | null | 2 | arm 1: Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet. arm 2: Ursodeoxycholic acid 28-30 mg/kg/day | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses intervention 2: Placebo for Urso | intervention 1: Ursodeoxycholic Acid intervention 2: Placebo | 7 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Jacksonville | Florida | United States | -81.65565 | 30.33218
Rochester | Minnesota | United States | -92.4699 | 44.02163
St Louis | Missouri | United States | -90.19789 | 38.62727
Omaha | Nebraska | United States | -95.94043 | 41.25626
Richmond | Virginia | ... | 0 | NCT00059202 |
[
3
] | 241 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | false | Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is ... | Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of ... | Osteoporosis Osteopenia | Bone Mineral Density Calcium | null | 2 | arm 1: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. arm 2: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. intervention 2: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. | intervention 1: Calcium carbonate intervention 2: Calcium Phosphate | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00074711 |
[
3
] | 106 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy. | null | Non-Small-Cell Lung Carcinoma | null | 2 | arm 1: E7389 28 day cycle arm 2: E7389 21 day cycle | [
0,
0
] | 2 | [
0,
0
] | intervention 1: E7389 1.4 mg/m\^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle. intervention 2: E7389 1.4 mg/m\^2 IV bolus on Days 1 and 8 of a 21 day cycle. | intervention 1: E7389 28 Day Cycle intervention 2: E7389 21 Day Cycle | 13 | Gilroy | California | United States | -121.56828 | 37.00578
Ocala | Florida | United States | -82.14009 | 29.1872
Baltimore | Maryland | United States | -76.61219 | 39.29038
Columbia | Missouri | United States | -92.33407 | 38.95171
Saint Joseph | Missouri | United States | -94.84663 | 39.76861
St Louis | Missouri | Un... | 0 | NCT00100932 | |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flo... | OBJECTIVES:
Primary
* Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.
Secondary
* Determine the response rate in patients treated with this regimen.
* Determine the median survival of patients treated with... | Colorectal Cancer | recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer | null | 1 | arm 1: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7 | [
0
] | 2 | [
2,
0
] | intervention 1: None intervention 2: None | intervention 1: bevacizumab intervention 2: capecitabine | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT00107315 |
[
5
] | 27 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszop... | Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings: re-experiencing symptoms including flashbacks, nightmares, and intrusive memories; physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of M... | Post-Traumatic Stress Disorders | PTSD Sleep disturbance Eszopiclone Double-blind Crossover | null | 2 | arm 1: Subjects received 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout. arm 2: Subjects received placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 ... | [
0,
2
] | 1 | [
0
] | intervention 1: The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout. | intervention 1: Eszopiclone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00120250 |
[
5
] | 219 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their cu... | null | HIV-Associated Lipodystrophy Syndrome | HIV infections | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks intervention 2: Protease inhibitor \[PI\] combination + 2 NRTIs | intervention 1: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) intervention 2: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) | 30 | Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Huntersville | North Carolina | United States | -80.84285 | 35.41069
Houston | Texas | United States | -95.36327 | 29.76328
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Toronto | Ontario | Cana... | 0 | NCT00135356 |
[
4
] | 255 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data. | null | Epilepsy, Partial | Partial Onset Seizures levetiracetam Epilepsy Keppra | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period. | intervention 1: levetiracetam (LEV) | 84 | Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Braden... | 0 | NCT00152516 |
[
3
] | 105 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Time to progression (physical examination and radiologic imaging | null | Ovarian Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol® | intervention 1: Paclitaxel | 0 | null | 0 | NCT00158379 | |
[
5
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | Obesity is known to affect the concentrations of certain medications in the body. Levofloxacin is a commonly used antibiotic. Based on what the investigators know about levofloxacin and how it moves through the body, obesity may affect levofloxacin concentrations. This study aims to show the effect of obesity on levofl... | Although the pharmacokinetics of levofloxacin have been consistent in various study populations, obese and critically ill individuals are likely to demonstrate altered distribution and clearance of levofloxacin, in addition to potentially having altered serum concentrations. Thus, the following study proposes to addres... | Obesity Critical Illness | null | 1 | arm 1: Patients receiving levofloxacin 750mg IV | [
0
] | 1 | [
0
] | intervention 1: PK in obesity | intervention 1: Levofloxacin 750 mg IV | 1 | Lexington | Kentucky | United States | -84.47772 | 37.98869 | 0 | NCT00176306 | |
[
3
] | 50 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To determine the activity of lenalidomide in relapsed or refractory aggressive NHL. | null | Non-Hodgkins Lymphoma | celgene cc-5013 CC5013 NHL Non-Hodgkins Lymphoma Revlimid | null | 1 | arm 1: Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated. | [
0
] | 1 | [
0
] | intervention 1: Capsules for oral administration. | intervention 1: Lenalidomide | 8 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Fountain Valley | California | United States | -117.95367 | 33.70918
Sacramento | California | United States | -121.4944 | 38.58157
Miami | Florida | United States | -80.19366 | 25.77427
Rochester | Minnesota | United States | -92.4699 | 44.02163
Omaha | Nebr... | 0 | NCT00179660 |
[
3
] | 4 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.
The subjects are being asked to participate in this research study. They are being offered vol... | null | Breast Carcinoma | null | 4 | arm 1: None arm 2: Tamoxifen 20 mg arm 3: Fulvestrant 250mg arm 4: Fulvestrant 500mg IM | [
4,
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 20mg intervention 2: 250mg intervention 3: 500 mg IM | intervention 1: Tamoxifen intervention 2: Fulvestrant intervention 3: Fulvestrant | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00183963 | |
[
0
] | 18 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | false | 0ALL | true | We are using anti-IgE to investigate the role of pulmonary mast cells in asthma. | Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells. | Asthma | null | 1 | arm 1: This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization. | [
0
] | 1 | [
0
] | intervention 1: Patients are administered Xolair | intervention 1: Xolair | 1 | Albuquerque | New Mexico | United States | -106.65114 | 35.08449 | 0 | NCT00189228 | |
[
5
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood. | null | Schizophrenia Schizoaffective Disorder | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 5-20 mg, oral, capsules, daily, 12 weeks. intervention 2: 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. | intervention 1: olanzapine intervention 2: risperidone | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00190749 | |
[
4
] | 355 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor. | null | Bladder Neoplasms | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) intervention 2: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) | intervention 1: Gemcitabine intervention 2: Placebo | 1 | Reinfeld | N/A | Germany | 10.49227 | 53.8311 | 0 | NCT00191477 | |
[
5
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typ... | Polycystic ovary syndrome (PCOS) affects 5-10% of women and may be viewed as the combination of hyperandrogenism with the classical features of the metabolic syndrome in young women. PCOS presents a unique opportunity to dissect the relationship between metabolic and cardiovascular risk and sleep disordered breathing (... | Polycystic Ovary Syndrome Obstructive Sleep Apnea | polycystic ovary syndrome metabolic syndrome obstructive sleep apnea impaired glucose tolerance insulin resistance | null | 10 | arm 1: One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm. arm 2: One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm. arm 3: One of the 3 treatment arms in Aim 1: depot leuprolide plus estrogen/progestin replacement. No subjects were randomize... | [
4,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 5 | [
1,
0,
0,
3,
3
] | intervention 1: CPAP is the most effective treatment available for sleep disordered breathing. CPAP provides a constant, controllable pressure to keep your upper airway open during sleep so that you can breathe normally. The pressure acts much in the same way as a splint and holds the airway open. intervention 2: Depot... | intervention 1: continuous positive airway pressure (CPAP) intervention 2: depot leuprolide plus estrogen/progestin replacement intervention 3: pioglitazone intervention 4: REM frag intervention 5: SWS supp | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00203996 |
[
0
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions. Using ultrasound we can see how arteries change with movement or even drugs. We want to use ultrasound to see how blood vess... | Spironolactone The starting dose of spironolactone is 1 mg/kg/day. After two weeks this dose will be doubled to the same maximum dose (2/mg/kg/day) as in RALES. If side effects occur or plasma urea and electrolytes became deranged the dose will be halved. Patients unable to tolerate the minimum dose will be withdrawn. ... | Congenital Disorders | Congenital Heart Disease Spironolactone >17 years old undergone Fontan procedure endothelial function | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 1 mg/kg/day; afer 2 weeks doubled to 2/mg/kg/day. Patient's with endothelium-dependent brachial artery vasodilation and single-ventricle should show improvement within 4-8 weeks. Patients and their labs who are receiving Spironolactone will be followed. | intervention 1: Spironolactone (drug) | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00211081 |
[
4
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the change in brachial artery reactivity in HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing antiretroviral regimen | HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with plasma HIV RNA \<500 copies/mL, who have LDL cholesterol levels \>130 mg/dL or fasting triglycerides levels \>200 mg/dL, will be randomized (1:1) to continue their current antiretroviral regimen or to switch the PI to ataza... | HIV Infection Hyperlipidemia | Atazanavir Endothelial function Treatment Experienced | null | 2 | arm 1: ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.
Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: atazanavir 400 mg once daily intervention 2: Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs | intervention 1: Atazanavir intervention 2: current antiretroviral regimen | 7 | San Diego | California | United States | -117.16472 | 32.71571
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Madison | Wisconsin | United States | -89.40123 | 43.07305
Buenos Aires | N/A | ... | 0 | NCT00225017 |
[
5
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo. | This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet Diagnostic and Statistical Manual-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients t... | Dysthymic Disorder | Dysthymic Disorder Dysthymia Depression Chronic Depression Wellbutrin XL | null | 2 | arm 1: Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day arm 2: Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Antidepressant medication intervention 2: Placebo | intervention 1: bupropion XL intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00225251 |
[
3
] | 48 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients ... | Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients ... | Breast Cancer | null | 1 | arm 1: single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion | [
0
] | 1 | [
0
] | intervention 1: trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44 | intervention 1: trastuzumab, docetaxel and carboplatin in dose dense regimen | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00232479 | |
[
4
] | 629 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn. | This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-b... | Heartburn | null | 2 | arm 1: Oral placebo tablet arm 2: oral rabeprazole 10 mg enteric-coated tablet | [
2,
0
] | 2 | [
0,
10
] | intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week single-blin... | intervention 1: rabeprazole sodium intervention 2: Placebo | 1 | Vista | California | United States | -117.24254 | 33.20004 | 0 | NCT00236184 | |
[
4
] | 619 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. | This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one week, single-b... | Heartburn | Heartburn Rabeprazole | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week sing... | intervention 1: rabeprazole sodium intervention 2: placebo | 1 | Lake Success | New York | United States | -73.71763 | 40.77066 | 0 | NCT00236197 |
[
3
] | 13 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in patients who have weakened immune systems.
PURPOSE: This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune syst... | OBJECTIVES:
Primary
* Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate.
Secondary
* Determine the 12-week survival rate in patients treated with this regimen.
* Determine the safety of this regime... | Infection Unspecified Adult Solid Tumor, Protocol Specific | infection unspecified adult solid tumor, protocol specific | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84. intervention 2: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour be... | intervention 1: caspofungin acetate intervention 2: voriconazole | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00238355 |
[
3
] | 172 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy. | Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of... | Carcinoma, Hepatocellular | PI-88 post resection hepatoma adjuvant therapy hepatectomy hepatoma | null | 3 | arm 1: Untreated control arm arm 2: PI-88 160 mg/day SC injection arm 3: PI-88 250 mg/day SC injection | [
4,
0,
0
] | 1 | [
0
] | intervention 1: Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks | intervention 1: PI-88 | 6 | Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 | 0 | NCT00247728 |
[
3
] | 80 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | null | The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the del... | Delayed graft function (DGF) is the most common allograft complication in the immediate kidney post-transplant period, affecting 25-35% of all patients who receive a cadaver graft, but rates up to 50% have been reported, especially in recipients of kidneys from marginal donors. It is an important clinical complication ... | Ischemia-Reperfusion Injury Kidney Diseases | Kidney transplantation Reperfusion Injury Survival | null | 3 | arm 1: Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours. arm 2: Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg... | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 ... | intervention 1: Reparixin continuous infusion intervention 2: reparixin intermittent infusion intervention 3: placebo infusion | 9 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Montpellier | N/A | France | 3.87635 | 43.61093
Paris | N/A | France | 2.3488 | 48.85341
Bergamo | N/A | Italy | 9.66721 | 45.69601
Brescia | N/A | Italy | 10.21472 | 45.53558
Padua | N/A | ... | 0 | NCT00248040 |
[
5
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms. | This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:
* To exa... | Schizophrenia | Schizophrenia Negative Symptoms Folate | null | 2 | arm 1: Participants will receive a 2 mg/ day dose of folate, for 12 weeks arm 2: Participants will receive a 2 mg/ day dose of placebo, for 12 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Folic acid taken as 2, 1mg capsule daily for 12 weeks intervention 2: Placebo taken as 2, 1mg capsule daily for 12 weeks | intervention 1: Folate intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00249288 |
[
4
] | 868 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months pri... | null | Psoriasis | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at ... | intervention 1: infliximab intervention 2: methotrexate | 0 | null | 0 | NCT00251641 | |
[
5
] | 146 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads w... | null | Hepatitis C, Chronic | chronic hepatitis C pegylated interferon alfa-2b ribavirin Australia | null | 2 | arm 1: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks arm 2: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks | [
1,
0
] | 4 | [
2,
2,
0,
0
] | intervention 1: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 2: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 ... | intervention 1: Peginterferon alfa-2b intervention 2: Peginterferon alfa-2b intervention 3: Ribavirin intervention 4: Ribavirin | 0 | null | 0 | NCT00255034 |
[
2,
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD). | The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to w... | Obsessive-Compulsive Disorder | null | 1 | arm 1: All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally. | [
0
] | 1 | [
0
] | intervention 1: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder | intervention 1: Memantine | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00264238 | |
[
4
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly ... | OBJECTIVES:
Primary
* Compare progression-free interval (PFI) in patients undergoing surgical resection and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial infusion of floxuridine.
Secondary
* Compare ov... | Colorectal Cancer Metastatic Cancer | liver metastases stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum | null | 2 | arm 1: Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. arm 2: Within 4-6 weeks after surgery and/or ablation,... | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1
Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2 intervention 2: Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg o... | intervention 1: capecitabine intervention 2: floxuridine intervention 3: oxaliplatin | 31 | Concord | California | United States | -122.03107 | 37.97798
Duarte | California | United States | -117.97729 | 34.13945
Loma Linda | California | United States | -117.26115 | 34.04835
Walnut Creek | California | United States | -122.06496 | 37.90631
Walnut Creek | California | United States | -122.06496 | 37.90631
New... | 0 | NCT00268463 |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may he... | OBJECTIVES:
Primary
* Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment with allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients with relapsed acute myeloid leukemia.
Secondary
* Determine the response rate, in terms of complete remission, in patients... | Leukemia | recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)... | null | 1 | arm 1: All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10\^7/kg.) | [
0
] | 5 | [
2,
2,
0,
0,
3
] | intervention 1: 10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses intervention 2: Cells infused per kg. 1.5-8.0 x 10\^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5... | intervention 1: aldesleukin intervention 2: therapeutic allogeneic lymphocytes intervention 3: cyclophosphamide intervention 4: fludarabine phosphate intervention 5: in vitro treated peripheral blood stem cell transplantation | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00274846 |
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